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NCT05669066 | COMPLETED | Arthropathy of Knee

Meditation and Opioid Consumption in Total Joint Replacement Patients Undergo Primary Total Hip and Knee Replacement
Sponsor:

Beth Israel Deaconess Medical Center

Information provided by (Responsible Party):

Jacob Drew

Brief Summary:

The main purpose of this study is to look at whether meditation techniques can help reduce pain and opioid use after surgery.

Condition or disease

Arthropathy of Knee

Osteo Arthritis Knee

Osteonecrosis

Meditation

Knee Osteoarthritis

Knee Disease

Knee Injuries

Opioid Use

Opioid Dependence

Opioid Use Disorder

Intervention/treatment

Mindful meditation

Phase

NA

Detailed Description:

Background: The Center for Disease Control identified prescription drug abuse as one of the top 5 current health threats in the US. Orthopedic Surgeons rank among the top 3 prescribers of opioid analgesics. Opioids are commonly used following total knee arthroplasty. Peri- operative protocols have been developed to reduce opioid intake however complications related to opioid analgesics remain problematic resulting in increased morbidity and mortality. There is a pressing need for non-narcotic adjuncts that can minimize /eliminate the use of opioids following elective total knee arthroplasty (TKA). Mind-body techniques including mindful medication (MM) have been demonstrated to reduce pain in acute and chronic disease states. Purpose: To determine whether mindful meditation, in conjunction with standard analgesic protocols, can impact opioid consumption, pain and function following elective primary TKA. Methods: a prospective, randomized control trial was conducted in patients aged 18-99 with degenerative joint disease of the knee presenting for primary TKA. Controls received standard perioperative analgesia. In additional to standard analgesia, study patients performed Isha-Krya meditation peri-operatively for 2 weeks followed by 4 weeks post operatively. Outcome measures: opioid consumption, time to discontinue opioids, Pain by Visual Analog Score (VAS), Patient-Reported Outcomes Measurement Information System 10 (PROMIS-10) Global Health Short Form, Knee injury and Osteoarthritis Outcome Score (KOOS)

Study Type : INTERVENTIONAL
Estimated Enrollment : 29 participants
Masking : NONE
Primary Purpose : PREVENTION
Official Title : The Effect of Mindful Meditation on Opioid Consumption in Patients Who Undergo Primary Total Hip and Knee Replacement
Actual Study Start Date : 2017-07-10
Estimated Primary Completion Date : 2021-12-03
Estimated Study Completion Date : 2021-12-16

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 89 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
Criteria
Inclusion Criteria
  • * • Male and female, ages 18-89 years
  • * Narcotic naive patients ("Narcotic naïve" for the purpose of this study will be no history of narcotic tolerance prior to surgery, defined by the FDA as greater than or equal to 60mg oral morphine equivalents per day for 7 days or longer)
  • * Scheduled for primary total knee replacement for osteoarthritis
  • * Willing to sign informed consent form
Exclusion Criteria
  • * • Surgery to be performed for other disease entities (e.g., inflammatory arthritis, post septic arthritis, posttraumatic arthritis or acute fracture)
  • * History of narcotic tolerance prior to surgery (defined by the FDA as greater than or equal to 60mg oral morphine equivalents per day for 7 days or longer)
  • * Currently taking non-narcotic analgesics other than acetaminophen and non-steroidal anti-inflammatory medications (e.g. Tramadol)
  • * History of pain syndromes (e.g., fibromyalgia, complex regional pain syndrome, chronic low back pain)
  • * Dementia or other disorder of cognitive function that precludes study consent and/or participation in the MM program
  • * In investigator's opinion, unable to complete study tasks over 12-month follow-up period
Meditation and Opioid Consumption in Total Joint Replacement Patients Undergo Primary Total Hip and Knee Replacement

Location Details

NCT05669066

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How to Participate

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Locations

Not yet recruiting

United States, Massachusetts

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States, 02215